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623 result(s) found, displaying 76 to 100
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Reference materialThe Australian Regulatory Guidelines for Medical Devices (ARGMD) is an index of Guidance.
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ChecklistsA checklist for sponsor intending to supply a therapeutic vaping device
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FormsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.
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User guideStep by step guide to submitting a Custom-Made Medical Device (CMMD) notification.
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Reference materialInformation on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/PGxWP/201914/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/189724/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/102046/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/ICH/449035/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/426390/2021
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/50549/2015
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/908/99
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Points to consider on the non-clinical assessment of the carcinogenic potential of insulin analogues
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/SWP/372/01 -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/2517/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3AB3a
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Reference materialEach year, approximately 40 new prescription medicines containing new active substances are registered.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/336031/2017
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/141697/2009
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Points to consider on clinical investigation of medicinal products for the treatment of acute stroke
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/560/1998 -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/482/99
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/863/98
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/1143/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Quality of medicines Q&A
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E9; CPMP/ICH/363/96